DNA vaccines are being developed to prevent infections by a variety of bacteria, viruses and parasties. Our research is directed towards understanding i) the mechanism by which the new form of vaccine induces a protective immune response, ii) whether such vaccines can induce deleterious autoimmune responses and iii) whether such vaccines induce protective immunity or tolerance when administered to newborns. DNA vaccines represent the cutting edge in vaccine development. A number of INDs for DNA vaccines have already been submitted to CBER, and considerably more are under active development. The FDA critically needs expertise in this field, including an understanding of the benefits, mode of action, and potential side effects of DNA vaccination.